Mirap Extended-Release Tablet 0.75 mg (Pramipexole Hydrochloride Dihydrate)

Adult dose

Idiopathic Parkinsonism Take this medicine once daily at the same time with water. Swallow it whole; do not chew, divide, or crush it. It may be taken with or without food. If you miss a dose, take it within 12 hours of the scheduled dose. If more than 12 hours have passed, skip the missed dose and take the next dose according to the regular schedule. 1. Patients with normal renal function 1) Initiation The starting dose is a total of 0.375mg/day, increased gradually. Increase the dose approximately once every 5-7 days, and do not increase it more frequently. If intolerable adverse reactions do not occur, the dose may be increased up to the maximum therapeutic dose. The increases recommended based on clinical trials are as follows. Week / Total daily dose (mg) / Dose (mg) 1 / 0.375 / 0.375 2 / 0.75 / 0.75 3 / 1.50 / 1.50 If further increases are needed, the dose may be increased by 0.75mg at weekly intervals, up to a maximum of 4.5mg per day. Patients already taking immediate-release pramipexole may be switched to this medicine at the same daily dose, with the first dose taken the following night. 2) Maintenance therapy The dose is 0.375mg to a maximum of 4.5mg per day. In pivotal clinical trials, efficacy was observed starting at a daily dose of 1.5mg during dose titration in both early and advanced Parkinson's disease. Some patients may experience additional therapeutic benefit at doses higher than 1.5mg. This regimen is particularly applicable to patients with advanced Parkinson's disease in whom a reduction in levodopa dose is planned. In patients taking this medicine with levodopa, a reduction in levodopa should be considered during dose escalation and maintenance treatment with pramipexole, as needed to avoid excessive dopaminergic stimulation. 2. Patients with renal impairment Elimination of pramipexole depends on renal function. For initiation, the following dosing schedule is proposed: Renal function / Starting dose (mg) / Maximum dose (mg) creatinine CL>50ml/min No adjustment of daily dose or dosing frequency is required. creatinine CL=30~50ml/min 0.375mg every 2 days / 2.25mg once daily creatinine CL<30ml/min Use of this medicine in these patients has not been adequately studied; consider using immediate-release pramipexole. If renal function declines during maintenance therapy, follow the above recommendations. 3. Discontinuation Reduce the daily dose by 0.75 mg/day until the daily dose is reduced to 0.75 mg, and thereafter reduce it by 0.375 mg/day each day.

This medication is used to treat Parkinson's disease and works by stimulating dopamine receptors to alleviate symptoms. During treatment with this medication, sudden sleepiness or severe drowsiness may occur; therefore, caution should be exercised when engaging in hazardous activities like driving or operating machinery. If you have sedative or sleep disorders or are taking other medications that can increase blood concentration, drowsiness may worsen, so consult your doctor. Psychotic symptoms such as hallucinations or confusion may occur, especially in the elderly or when combined with other Parkinson's disease medications, increasing the risk. Orthostatic hypotension symptoms, such as sudden drops in blood pressure, may appear; therefore, patients with cardiovascular diseases should frequently check their blood pressure during dosage increments. Patients with impaired kidney function should have their medication dosage adjusted, and it is not to be administered to those with hypersensitivity. This medication can cause various side effects, with nausea, dizziness, constipation, drowsiness, and hallucinations being commonly reported; if these symptoms are severe, consult with medical personnel. Additionally, this medication may cause behavioral changes such as compulsive buying, pathological gambling, and increased libido in some patients, so those around them should observe closely. Pregnant women or nursing mothers should carefully consider the effects on the fetus or baby when using this medication. In elderly patients, medication concentration may increase due to reduced kidney function, requiring dosage adjustments and monitoring for side effects. This medication can interact with other medications, so if you are taking other medications, be sure to inform your doctor or pharmacist. In case of overdose, symptoms such as nausea, vomiting, hallucinations, and hypotension may occur, and you should visit a medical facility immediately; there is no specific antidote. Finally, this medication should be stored in a container that protects it from light and moisture, out of reach of children.

• Drowsiness
• hallucinations
• confusion
• nausea
• dizziness
• vertigo
• insomnia
• constipation
• weakness
• amnesia

This medication is sensitive to light, so it should be stored in a container that blocks light. Additionally, it should be stored at room temperature between 1 to 30 degrees Celsius, in a dry place free from moisture.

Appearance

White or light gray biconvex round extended-release tablet

Package unit

100 tablets (10 tablets/PTP packaging x 10), 30 tablets/bottle, 100 tablets/bottle